文件名稱 |
蒸汽滅菌器再驗證 |
編 號 |
SYZ03-028 |
編制依據(jù) |
設備驗證管理制度(YZ01-002) |
共37頁 |
編 制 人 |
|
審 核 人 |
|
批 準 人 |
|
編制日期 |
年 月 日 |
審核日期 |
年 月 日 |
批準日期 |
年 月 日 |
頒發(fā)部門 |
設備處 |
生效日期 |
|
目 錄
驗證小組……………………………………………………………1
驗證方案……………………………………………………………2
驗證方案審查結(jié)論…………………………………………………8
驗證實施計劃書……………………………………………………9
驗證報告(1)……………………………………………………10
驗證結(jié)果報告書(1)……………………………………………22
驗證證書(1)……………………………………………………23
驗證報告(2)……………………………………………………24
驗證結(jié)果報告書(2)……………………………………………36
驗證證書(2)……………………………………………………37
驗證小組:
組長:蘇振波
組員:孫忠輝、孫桂菊、沈偉、高云峰、袁玉敏、張若萍
沈陽同聯(lián)藥業(yè)有限公司
文件名稱 |
蒸汽滅菌柜再驗證方案 |
編 號 |
SYZ-F-03-028 |
編制依據(jù) |
設備驗證管理制度(YZ01-002) |
共14頁 |
編 制 人 |
|
審 核 人 |
|
批 準 人 |
|
編制日期 |
年 月 日 |
審核日期 |
年 月 日 |
批準日期 |
年 月 日 |
頒發(fā)部門 |
設備處 |
生效日期 |
|
1、概述
蒸汽
滅菌器位于口服液滅菌室。本次蒸汽滅菌柜的驗證為再驗證。采用同步驗證的方式進行,對連續(xù)三批耆鹿逐痹口服液的藥液配制生產(chǎn),對蒸汽滅菌柜進行驗證。本次驗證不再進行設計驗證(DQ)及安裝驗證(IQ)。本方案的制定依據(jù)蒸汽滅菌柜(120406-02-02)標準操作規(guī)程進行制定。
由于該設備一直處于良好的運行狀態(tài),本次確認是在繼上次確認結(jié)束后,無任何偏差、變更情況下對設備性能進行的再確認,故在滅菌效果確認時,無需考察空載狀態(tài),如滿載及熱溫度分布均一性能夠達到驗證可接受標準,即可證明設備性能穩(wěn)定。
2、驗證目的:
本再驗證方案的目的是以文件形式證明口服液生產(chǎn)用蒸汽滅菌柜和它的附件系統(tǒng)能夠按照預定運行范圍運行,在預先設定好的范圍內(nèi)生產(chǎn)產(chǎn)品。
3、驗證范圍:
口服液生產(chǎn)用蒸汽滅菌柜
4、驗證小組職責
驗證小組成員 |
部門及職位 |
職 責 |
組長 |
蘇振波 |
設備處處長 |
負責再驗證方案驗證報告的審批 |
組員 |
孫忠輝 |
機修車間主任 |
負責擬定方案,實施驗證,完成驗證報告。 |
沈偉 |
設備員 |
負責方案的實施驗證。 |
張若萍 |
計量室主任 |
負責儀器、儀表、器具等的校正。 |
包君 |
質(zhì)保處 |
參與和協(xié)調(diào)驗證工作。 |
袁玉敏 |
QA |
生產(chǎn)現(xiàn)場監(jiān)督員 |
孫桂菊 |
二車間主任 |
監(jiān)督驗證的實施 |
高云峰 |
生產(chǎn)技術(shù)員 |
參與驗證實施過程。 |
李麗華 |
質(zhì)量部部長 |
驗證方案及驗證報告的批準 |
鞠濤 |
總工程師 |
驗證方案及驗證報告的批準、發(fā)放驗證證書、驗證再驗證周期 |
魏影 |
總經(jīng)理 |
簽發(fā)驗證證書 |
5、驗證正文
5.1驗證過程中使用的儀器儀表校驗情況
本次所用計量器具及儀表等校驗情況。見附表1
5.2 運行確認
按蒸汽滅菌柜操作規(guī)程要求運行,對蒸汽滅菌柜的各項功能進行檢查。具體檢查項如下:
1)對設備外觀進行檢查,蒸汽滅菌柜內(nèi)外表面應無腐蝕或破損。
2)與四周、建筑物距離在0.20米以上有足夠的空間維護保養(yǎng)。
3)上蓋密封圈應完好無撕裂或老化現(xiàn)象。
4)管路應密封無泄漏。見附表2
5.3性能確認
5.3.1熱電偶放置方式的確認
將12支熱電偶放到滅菌鍋內(nèi)不同位置,測溫點不得接觸金屬表面和其它表面,具體放置位置見如下示意圖:
5.3.2觀察無紙記錄儀記錄運行溫度
取樣點及溫度探頭位置圖示:
圖一
取樣點分層 |
取樣點位置 |
熱電偶編號 |
取樣點位置 |
熱電偶編號 |
取樣點位置 |
熱電偶編號 |
1 |
01 |
2 |
02 |
3 |
03 |
4 |
04 |
5 |
05 |
4 |
06 |
7 |
07 |
8 |
08 |
9 |
09 |
10 |
10 |
11 |
11 |
12 |
12 |
滿載及熱力分布取樣點編號見附表1
5.3.2熱力分布溫度分布均一性確認
熱力分布溫度均一性確認在滿載狀態(tài)下進行,將溫度驗證儀探頭放在被滅菌的物品內(nèi)部,以考察滅菌效果。該項確認同樣在105℃/30min每個工藝參數(shù)條件下連續(xù)進行三次。
可接受標準:各測試點溫度與設定值溫差≤2℃
各測試點溫度范圍103—107℃;
6.3 數(shù)據(jù)統(tǒng)計及分析
分別統(tǒng)計滿載熱力分布均一性確認,統(tǒng)計結(jié)果如下。
105℃滿載溫度分布統(tǒng)計結(jié)果 單位:105℃
試驗次數(shù) |
項目 |
熱電偶編號 |
01 |
02 |
03 |
04 |
05 |
06 |
07 |
08 |
09 |
10 |
11 |
12 |
1 |
最大值 |
|
|
|
|
|
|
|
|
|
|
|
|
最小值 |
|
|
|
|
|
|
|
|
|
|
|
|
2 |
最大值 |
|
|
|
|
|
|
|
|
|
|
|
|
最小值 |
|
|
|
|
|
|
|
|
|
|
|
|
3 |
最大值 |
|
|
|
|
|
|
|
|
|
|
|
|
最小值 |
|
|
|
|
|
|
|
|
|
|
|
|
6.4 驗證合格標準
6.4.1該設備在滿載及熱力分布溫度均一性能達到相應的可接受標準。
6.5 變更與偏差處理
確認過程中如果出現(xiàn)偏差或變更,應立即通知質(zhì)保處,按照偏差處理程序或變更控制程序?qū)ζ涮幚怼K衅詈妥兏凑障鄳?guī)程得到有效處理后,確認方可進入下一步驟。原始的偏差表或變更表經(jīng)過批準后,其復印件必須附在最終的確認報告中。
確認過程無變更與偏差。
評價結(jié)果:是否有偏差。
6.7 確認結(jié)果評定與結(jié)論
驗證工作小組組長對確認結(jié)果進行綜合評審,做出確認結(jié)論。驗證領導小組組長發(fā)放驗證證書,對確認結(jié)果的評審應包括:
(1) 驗證結(jié)果是否有遺漏?
驗證結(jié)果無遺漏
(2) 驗證過程中的偏差、變更是否關(guān)閉?
驗證過程無偏差及變更
(3) 驗證實施過程中對驗證方案有無修改,修改原因、依據(jù)、是否經(jīng)過批準?
驗證實施過程對方案無修改
(4) 驗證記錄是否完整?
驗證記錄完整、真實
(5) 驗證結(jié)果是否符合標準要求?
驗證結(jié)果能夠達到驗證合格標準。
附表1
序號 |
儀器儀表名稱 |
型號 |
編號 |
范圍 |
校正日期 |
有效期 |
1 |
|
|
|
|
|
|
2 |
|
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|
|
3 |
|
|
|
|
|
|
4 |
|
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5 |
|
|
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6 |
|
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7 |
|
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8 |
|
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|
9 |
|
|
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10 |
|
|
|
|
|
|
11 |
|
|
|
|
|
|
12 |
|
|
|
|
|
|
附表2:
設備運行確認表
項目 |
可接受標準 |
結(jié)果 |
結(jié)論 |
設備情況 |
蒸汽滅菌柜內(nèi)外表面應無腐蝕或破損。 |
|
|
位置 |
與四周、建筑物距離在0.20米以上有足夠的空間維護保養(yǎng) |
|
密封圈 |
上蓋密封圈應完好無撕裂或老化現(xiàn)象 |
|
管路 |
管路應密封無泄漏 |
|
檢查人 |
|
復核人 |
|
檢查日期 |
|
|
|
|
|
|
|
附表3:
105℃滿載熱分布測試記錄(第1次)
設備編號: 105℃
位置
時間 |
1 |
2 |
3 |
4 |
5 |
6 |
7 |
8 |
9 |
10 |
11 |
12 |
△T |
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測試人 復核人: 日期:
再驗證方案審查結(jié)論
方案名稱:
蒸汽滅菌柜再驗證方案
審查結(jié)果:經(jīng)驗證領導小組討論認為該方案設計合理,能夠達到驗證目的。
批準執(zhí)行。
驗證小組:
批準人:
批準日期: 年 月 日
再驗證實施計劃書
題目 |
蒸汽滅菌柜再驗證方案 |
目的/概要 |
檢查并驗證設備運行及性能符合生產(chǎn)工藝要求,符合GMP規(guī)定。 |
預期結(jié)果 |
設備的運行及性能符合GMP要求,滿足工藝生產(chǎn)要求。 |
驗證方法 |
按規(guī)范、生產(chǎn)技術(shù)資料、標準生產(chǎn)操作規(guī)程、技術(shù)要求檢測各項性能。 |
計劃實施時間 |
2013年10月 |
負責者(部門) |
驗證小組 |
變更記錄(改定者、改定日、變更事項、理由) |
|
沈陽同聯(lián)藥業(yè)有限公司
文件名稱 |
蒸汽滅菌柜再驗證報告(1) |
編 號 |
SYZ-B-03-028-01 |
編制依據(jù) |
設備驗證管理制度(YZ01-002) |
共14 頁 |
編 制 人 |
|
審 核 人 |
|
批 準 人 |
|
編制日期 |
年 月 日 |
審核日期 |
年 月 日 |
批準日期 |
年 月 日 |
頒發(fā)部門 |
設備處 |
生效日期 |
|
1、概述
蒸汽滅菌柜(YXQ-WF22)位于口服液滅菌室,生產(chǎn)廠家長春市醫(yī)用設備廠。本次蒸汽滅菌柜的驗證為再驗證。采用同步驗證的方式進行,對連續(xù)三批耆鹿逐痹口服液的藥液配制生產(chǎn),對蒸汽滅菌柜進行驗證。本次驗證不再進行設計驗證(DQ)及安裝驗證(IQ)。本方案的制定依據(jù)蒸汽滅菌柜(120406-02-02)標準操作規(guī)程進行制定。
由于該設備一直處于良好的運行狀態(tài),本次確認是在繼上次確認結(jié)束后,無任何偏差、變更情況下對設備性能進行的再確認,故在滅菌效果確認時,無需考察空載狀態(tài),如滿載及熱力分布溫度分布均一性能夠達到驗證可接受標準,即可證明設備性能穩(wěn)定。
2、驗證目的:
本再驗證方案的目的是以文件形式證明口服液生產(chǎn)用蒸汽滅菌柜和它的附件系統(tǒng)能夠按照預定運行范圍運行,在預先設定好的范圍內(nèi)生產(chǎn)產(chǎn)品。
3、驗證范圍:
口服液生產(chǎn)用蒸汽滅菌柜
4、驗證小組職責
驗證小組成員 |
部門及職位 |
職 責 |
組長 |
蘇振波 |
設備處處長 |
負責再驗證方案驗證報告的審批 |
組員 |
孫忠輝 |
機修車間主任 |
負責擬定方案,實施驗證,完成驗證報告。 |
沈偉 |
設備員 |
負責方案的實施驗證。 |
張若萍 |
計量室主任 |
負責儀器、儀表、器具等的校正。 |
包君 |
質(zhì)保處 |
參與和協(xié)調(diào)驗證工作。 |
袁玉敏 |
QA |
生產(chǎn)現(xiàn)場監(jiān)督員 |
孫桂菊 |
二車間主任 |
監(jiān)督驗證的實施 |
高云峰 |
生產(chǎn)技術(shù)員 |
參與驗證實施過程。 |
李麗華 |
質(zhì)量部部長 |
驗證方案及驗證報告的批準 |
鞠濤 |
總工程師 |
驗證方案及驗證報告的批準、發(fā)放驗證證書、驗證再驗證周期 |
魏影 |
總經(jīng)理 |
簽發(fā)驗證證書 |
5、驗證正文
5.1驗證過程中使用的儀器儀表校驗情況
本次所用計量器具及儀表等校驗情況。見附表1
5.2 運行確認
按蒸汽滅菌柜操作規(guī)程要求運行,對蒸汽滅菌柜的各項功能進行檢查。具體檢查項如下:
1)對設備外觀進行檢查,蒸汽滅菌柜內(nèi)外表面應無腐蝕或破損。
2)與四周、建筑物距離在0.20米以上有足夠的空間維護保養(yǎng)。
3)上蓋密封圈應完好無撕裂或老化現(xiàn)象。
4)管路應密封無泄漏。見附表2
5.3性能確認
5.3.1熱電偶放置方式的確認
將12支熱電偶放到滅菌鍋內(nèi)不同位置,測溫點不得接觸金屬表面和其它表面,具體放置位置見如下示意圖:
5.3.2觀察無紙記錄儀記錄運行溫度
取樣點及溫度探頭位置圖示:
圖一
取樣點分層 |
取樣點位置 |
熱電偶編號 |
取樣點位置 |
熱電偶編號 |
取樣點位置 |
熱電偶編號 |
1 |
01 |
2 |
02 |
3 |
03 |
4 |
04 |
5 |
05 |
4 |
06 |
7 |
07 |
8 |
08 |
9 |
09 |
10 |
10 |
11 |
11 |
12 |
12 |
滿載及熱力分布取樣點編號見附表1
5.3.2熱力分布溫度分布均一性確認
熱力分布溫度均一性確認在滿載狀態(tài)下進行,將溫度驗證儀探頭放在被滅菌的物品內(nèi)部,以考察滅菌效果。該項確認同樣在105℃/30min每個工藝參數(shù)條件下連續(xù)進行三次。
可接受標準:各測試點溫度與設定值溫差≤2℃
各測試點溫度范圍103—107℃;
6.3 數(shù)據(jù)統(tǒng)計及分析
分別統(tǒng)計滿載熱力分布均一性確認,統(tǒng)計結(jié)果如下。
105℃滿載溫度分布統(tǒng)計結(jié)果 單位:105℃
試驗次數(shù) |
項目 |
熱電偶編號 |
01 |
02 |
03 |
04 |
05 |
06 |
07 |
08 |
09 |
10 |
11 |
12 |
1 |
最大值 |
106.8 |
105.6 |
106.2 |
106.7 |
106.5 |
105.6 |
106.5 |
106.6 |
106.5 |
105.5 |
105.4 |
106.7 |
最小值 |
105.0 |
105.0 |
105.0 |
105.1 |
104.9 |
105.0 |
105.0 |
105.1 |
105.2 |
105.0 |
104.7 |
105.0 |
2 |
最大值 |
106.8 |
105.7 |
106.4 |
106.7 |
106.8 |
105.7 |
106.5 |
106.6 |
106.5 |
105.8 |
105.6 |
106.7 |
最小值 |
105.2 |
105.1 |
105.0 |
105.1 |
104.9 |
105.0 |
104.8 |
105.1 |
105.2 |
104.8 |
104.5 |
104.8 |
3 |
最大值 |
106.8 |
105.8 |
106.3 |
106.7 |
106.8 |
106.2 |
106.5 |
106.5 |
106.5 |
105.8 |
105.6 |
106.7 |
最小值 |
105.2 |
105.1 |
105.0 |
105.1 |
104.9 |
105.0 |
104.9 |
105.0 |
105.2 |
104.8 |
104.2 |
105.0 |
6.4 驗證合格標準
6.4.1該設備在滿載及熱力分布溫度均一性能達到相應的可接受標準。
6.5 變更與偏差處理
確認過程中如果出現(xiàn)偏差或變更,應立即通知質(zhì)保處,按照偏差處理程序或變更控制程序?qū)ζ涮幚怼K衅詈妥兏凑障鄳?guī)程得到有效處理后,確認方可進入下一步驟。原始的偏差表或變更表經(jīng)過批準后,其復印件必須附在最終的確認報告中。
確認過程無變更與偏差。
評價結(jié)果:__________________。
6.7 確認結(jié)果評定與結(jié)論
驗證工作小組組長對確認結(jié)果進行綜合評審,做出確認結(jié)論。驗證領導小組組長發(fā)放驗證證書,對確認結(jié)果的評審應包括:
(1) 驗證結(jié)果是否有遺漏?
驗證結(jié)果: __________________。
(2) 驗證過程中的偏差、變更是否關(guān)閉?
驗證過程: __________________。
(3) 驗證實施過程中對驗證方案有無修改,修改原因、依據(jù)、是否經(jīng)過批準?
驗證實施過程: __________________。
(4) 驗證記錄是否完整?
驗證記錄完整、真實
(5) 驗證結(jié)果是否符合標準要求?
驗證結(jié)果能夠達到驗證合格標準。
附表1
序號 |
儀器儀表名稱 |
型號 |
編號 |
范圍 |
校正日期 |
有效期 |
1 |
熱電偶 |
HSB-600R |
TI10-15-1-1 |
0~300℃ |
2013-03-26 |
一年 |
2 |
熱電偶 |
HSB-600R |
TI10-15-1-2 |
0~300℃ |
2013-03-26 |
一年 |
3 |
熱電偶 |
HSB-600R |
TI10-15-1-3 |
0~300℃ |
2013-03-26 |
一年 |
4 |
熱電偶 |
HSB-600R |
TI10-15-1-4 |
0~300℃ |
2013-03-26 |
一年 |
5 |
熱電偶 |
HSB-600R |
TI10-15-1-5 |
0~300℃ |
2013-03-26 |
一年 |
6 |
熱電偶 |
HSB-600R |
TI10-15-1-6 |
0~300℃ |
2013-03-26 |
一年 |
7 |
熱電偶 |
HSB-600R |
TI10-15-1-7 |
0~300℃ |
2013-03-26 |
一年 |
8 |
熱電偶 |
HSB-600R |
TI10-15-1-8 |
0~300℃ |
2013-03-26 |
一年 |
9 |
熱電偶 |
HSB-600R |
TI10-15-1-9 |
0~300℃ |
2013-03-26 |
一年 |
10 |
熱電偶 |
HSB-600R |
TI10-15-1-10 |
0~300℃ |
2013-03-26 |
一年 |
11 |
熱電偶 |
HSB-600R |
TI10-15-1-11 |
0~300℃ |
2013-03-26 |
一年 |
12 |
熱電偶 |
HSB-600R |
TI10-15-1-12 |
0~300℃ |
2013-03-26 |
一年 |
附表2:
設備運行確認表
項目 |
可接受標準 |
結(jié)果 |
結(jié)論 |
設備情況 |
蒸汽滅菌柜內(nèi)外表面應無腐蝕或破損。 |
|
|
位置 |
與四周、建筑物距離在0.20米以上有足夠的空間維護保養(yǎng) |
|
密封圈 |
上蓋密封圈應完好無撕裂或老化現(xiàn)象 |
|
管路 |
管路應密封無泄漏 |
|
檢查人 |
|
復核人 |
|
檢查日期 |
|
|
|
|
|
|
|
附表3:
105℃滿載熱分布測試記錄(第1次)
設備編號:120406-02-01
溫度:105℃
位置
時間 |
1 |
2 |
3 |
4 |
5 |
6 |
7 |
8 |
9 |
10 |
11 |
12 |
△T |
2013-10-10 17:12 |
105.0 |
105.3 |
105.0 |
105.1 |
105.2 |
105.2 |
105.1 |
105.2 |
106.1 |
105.3 |
104.9 |
105.1 |
1.2 |
2013-10-10 17:13 |
105.1 |
105.2 |
105.2 |
105.1 |
105.4 |
105.1 |
105.2 |
105.3 |
105.5 |
105.2 |
104.8 |
105.0 |
0.7 |
2013-10-10 17:14 |
105.3 |
105.4 |
105.2 |
105.3 |
105.6 |
105.2 |
105.3 |
105.2 |
106.2 |
105.4 |
105.2 |
105.1 |
1.1 |
2013-10-10 17:15 |
106.2 |
105.2 |
105.0 |
105.4 |
105.3 |
105.3 |
105.1 |
105.4 |
106.4 |
105.2 |
105.2 |
105.4 |
1.4 |
2013-10-10 17:16 |
106.5 |
105.4 |
105.3 |
105.2 |
105.2 |
105.2 |
105.4 |
105.2 |
106.5 |
105.4 |
105.3 |
105.2 |
1.3 |
2013-10-10 17:17 |
105.3 |
105.3 |
105.2 |
105.3 |
105.1 |
105.1 |
105.5 |
105.6 |
106.4 |
105.3 |
105.4 |
105.3 |
1.3 |
2013-10-10 17:18 |
106.5 |
105.2 |
105.1 |
105.6 |
105.4 |
105.4 |
105.2 |
105.5 |
106.5 |
105.2 |
105.2 |
105.2 |
1.4 |
2013-10-10 17:19 |
106.4 |
105.4 |
105.0 |
105.4 |
105.5 |
105.4 |
105.5 |
105.2 |
105.2 |
105.4 |
105.3 |
105.1 |
1.4 |
2013-10-10 17:20 |
106.8 |
105.0 |
106.1 |
105.3 |
105.2 |
105.0 |
105.2 |
105.4 |
106.3 |
105.0 |
105.2 |
105.2 |
1.8 |
2013-10-10 17:21 |
105.5 |
105.2 |
106.2 |
105.2 |
106.2 |
105.1 |
105.4 |
105.2 |
106.5 |
105.2 |
105.2 |
106.7 |
1.6 |
2013-10-10 17:22 |
105.2 |
105.1 |
105.7 |
105.2 |
106.0 |
105.4 |
105.3 |
105.2 |
106.4 |
105.1 |
105.4 |
106.3 |
1.3 |
2013-10-10 17:23 |
105.2 |
105.3 |
105.4 |
105.2 |
105.4 |
105.5 |
105.2 |
105.3 |
105.5 |
105.3 |
105.2 |
106.4 |
1.2 |
2013-10-10 17:24 |
105.3 |
105.2 |
105.1 |
105.3 |
105.2 |
105.6 |
105.2 |
105.2 |
105.6 |
105.2 |
105.1 |
106.0 |
0.9 |
2013-10-10 17:25 |
105.2 |
105.4 |
105.2 |
106.7 |
105.2 |
105.4 |
105.4 |
105.4 |
105.4 |
105.4 |
105.1 |
105.8 |
1.6 |
2013-10-10 17:26 |
105.4 |
105.1 |
105.3 |
106.2 |
105.5 |
105.5 |
105.0 |
105.4 |
105.5 |
105.1 |
105.2 |
106.3 |
1.3 |
2013-10-10 17:27 |
105.6 |
105.2 |
105.2 |
106.1 |
105.2 |
105.2 |
105.4 |
105.2 |
105.2 |
105.2 |
105.3 |
105.4 |
0.9 |
2013-10-10 17:28 |
105.7 |
105.3 |
106.2 |
105.7 |
105.2 |
105.2 |
105.2 |
105.1 |
105.2 |
105.3 |
105.2 |
105.2 |
1.1 |
2013-10-10 17:29 |
105.2 |
105.4 |
105.2 |
105.2 |
106.2 |
105.3 |
105.2 |
105.2 |
105.3 |
105.4 |
105.3 |
105.2 |
1.0 |
2013-10-10 17:30 |
105.4 |
105.2 |
105.3 |
105.4 |
105.0 |
105.2 |
105.3 |
105.3 |
105.2 |
105.2 |
105.2 |
105.1 |
0.4 |
2013-10-10 17:31 |
105.3 |
105.6 |
105.2 |
105.3 |
104.9 |
105.4 |
105.2 |
106.5 |
105.4 |
105.5 |
105.2 |
105.2 |
1.6 |
2013-10-10 17:32 |
106.4 |
105.2 |
105.4 |
105.2 |
105.6 |
105.2 |
105.4 |
106.4 |
105.2 |
105.2 |
105.1 |
105.2 |
1.3 |
2013-10-10 17:33 |
106.6 |
105.1 |
105.3 |
105.4 |
105.4 |
105.4 |
105.2 |
106.6 |
105.4 |
105.1 |
104.8 |
105.3 |
1.8 |
2013-10-10 17:34 |
106.7 |
105.2 |
105.2 |
105.6 |
105.7 |
105.2 |
105.2 |
105.2 |
105.2 |
105.2 |
104.7 |
105.2 |
2.0 |
2013-10-10 17:35 |
105.2 |
105.2 |
105.2 |
105.2 |
105.8 |
105.3 |
105.3 |
105.3 |
105.3 |
105.2 |
105.4 |
106.5 |
1.3 |
2013-10-10 17:36 |
105.4 |
105.3 |
105.1 |
105.4 |
106.5 |
105.4 |
105.2 |
105.2 |
105.4 |
105.3 |
105.4 |
105.4 |
1.4 |
2013-10-10 17:37 |
105.3 |
105.2 |
105.4 |
105.3 |
106.4 |
105.6 |
105.4 |
106.5 |
105.7 |
105.2 |
105.2 |
105.2 |
1.3 |
2013-10-10 17:38 |
105.2 |
105.0 |
106.2 |
105.2 |
105.8 |
105.2 |
105.4 |
105.1 |
105.2 |
105.0 |
105.4 |
105.6 |
1.2 |
2013-10-10 17:39 |
105.0 |
105.4 |
105.2 |
105.1 |
105.4 |
105.3 |
106.3 |
105.4 |
105.3 |
105.4 |
105.3 |
105.4 |
1.3 |
2013-10-10 17:40 |
105.1 |
105.2 |
105.1 |
105.1 |
105.2 |
105.2 |
106.5 |
105.4 |
105.2 |
105.2 |
105.2 |
105.5 |
1.4 |
2013-10-10 17:41 |
105.3 |
105.3 |
105.2 |
105.3 |
105.3 |
105.4 |
106.4 |
105.2 |
105.4 |
105.3 |
105.4 |
105.2 |
1.2 |
2013-10-10 17:42 |
105.4 |
105.2 |
105.3 |
105.4 |
105.2 |
105.2 |
106.2 |
105.2 |
105.2 |
105.2 |
105.2 |
105.4 |
1.0 |
最大值 |
106.8 |
105.6 |
106.2 |
106.7 |
106.5 |
105.6 |
106.5 |
106.6 |
106.5 |
105.5 |
105.4 |
106.7 |
— |
最小值 |
105.0 |
105.0 |
105.0 |
105.1 |
104.9 |
105.0 |
105.0 |
105.1 |
105.2 |
105.0 |
104.7 |
105.0 |
— |
測試人 復核人: 日期:
105℃滿載熱分布測試記錄(第2次)
設備編號:120406-02-01
溫度:℃
位置
時間 |
1 |
2 |
3 |
4 |
5 |
6 |
7 |
8 |
9 |
10 |
11 |
12 |
△T |
2013-10-11 17:12 |
105.4 |
105.7 |
105.4 |
105.7 |
105.2 |
105.3 |
105.1 |
105.2 |
105.8 |
105.2 |
104.9 |
105.2 |
0.9 |
2013-10-11 17:13 |
105.4 |
105.3 |
105.2 |
105.1 |
105.4 |
105.1 |
105.2 |
105.3 |
105.5 |
105.2 |
104.8 |
105.0 |
0.7 |
2013-10-11 17:14 |
105.2 |
105.4 |
105.2 |
106.0 |
105.6 |
105.2 |
105.3 |
105.2 |
106.2 |
105.4 |
105.2 |
105.1 |
1.1 |
2013-10-11 17:15 |
106.2 |
105.3 |
105.0 |
106.2 |
105.3 |
105.3 |
105.1 |
105.4 |
106.4 |
105.2 |
105.2 |
105.4 |
1.4 |
2013-10-11 17:16 |
106.5 |
105.4 |
105.3 |
105.2 |
105.2 |
105.2 |
105.4 |
105.2 |
106.5 |
105.4 |
105.3 |
105.2 |
1.3 |
2013-10-11 17:17 |
106.2 |
105.5 |
105.2 |
106.4 |
105.1 |
105.0 |
105.5 |
105.6 |
106.4 |
105.3 |
105.4 |
105.3 |
1.4 |
2013-10-11 17:18 |
106.5 |
105.2 |
105.4 |
105.6 |
105.4 |
105.4 |
105.2 |
105.5 |
106.5 |
105.1 |
105.2 |
105.2 |
1.4 |
2013-10-11 17:19 |
106.4 |
105.4 |
105.0 |
106.1 |
105.5 |
105.4 |
105.5 |
105.2 |
105.2 |
105.3 |
105.5 |
105.1 |
1.4 |
2013-10-11 17:20 |
106.8 |
105.2 |
106.1 |
106.2 |
105.2 |
105.0 |
105.2 |
105.4 |
106.3 |
105.1 |
105.2 |
105.2 |
1.8 |
2013-10-11 17:21 |
106.4 |
105.2 |
106.2 |
105.8 |
106.2 |
105.1 |
105.4 |
105.2 |
106.5 |
105.2 |
105.2 |
106.7 |
1.6 |
2013-10-11 17:22 |
106.3 |
105.2 |
105.2 |
105.3 |
106.0 |
105.4 |
105.3 |
105.6 |
106.4 |
105.1 |
105.4 |
106.3 |
1.3 |
2013-10-11 17:23 |
106.0 |
105.3 |
105.4 |
105.6 |
105.4 |
105.5 |
105.2 |
105.3 |
106.2 |
105.4 |
105.2 |
106.4 |
1.2 |
2013-10-11 17:24 |
105.9 |
105.5 |
105.5 |
105.4 |
105.2 |
105.7 |
105.2 |
105.2 |
106.1 |
105.2 |
105.1 |
106.0 |
1.0 |
2013-10-11 17:25 |
105.8 |
105.3 |
105.2 |
106.7 |
106.4 |
105.4 |
105.4 |
105.5 |
105.4 |
105.4 |
104.7 |
105.8 |
2.0 |
2013-10-11 17:26 |
105.7 |
105.4 |
105.4 |
106.2 |
106.8 |
105.5 |
104.8 |
105.4 |
105.5 |
105.1 |
104.8 |
106.3 |
2.0 |
2013-10-11 17:27 |
105.4 |
105.2 |
106.4 |
106.1 |
105.3 |
105.2 |
105.4 |
105.2 |
105.2 |
105.2 |
105.3 |
105.4 |
1.2 |
2013-10-11 17:28 |
105.4 |
105.3 |
106.2 |
105.7 |
105.2 |
105.2 |
105.1 |
105.1 |
105.2 |
105.8 |
105.6 |
105.2 |
1.1 |
2013-10-11 17:29 |
105.3 |
105.6 |
105.2 |
105.9 |
106.2 |
105.3 |
105.3 |
105.2 |
105.3 |
105.4 |
105.3 |
105.2 |
1.0 |
2013-10-11 17:30 |
105.6 |
105.2 |
105.3 |
105.4 |
106.5 |
105.2 |
105.5 |
105.3 |
105.2 |
105.2 |
105.2 |
104.9 |
1.6 |
2013-10-11 17:31 |
105.8 |
105.6 |
105.2 |
105.3 |
104.9 |
105.4 |
105.2 |
106.5 |
105.4 |
105.5 |
105.2 |
104.8 |
1.7 |
2013-10-11 17:32 |
106.4 |
105.2 |
105.8 |
105.8 |
105.6 |
105.2 |
105.4 |
106.4 |
105.2 |
105.2 |
105.1 |
105.2 |
1.3 |
2013-10-11 17:33 |
106.2 |
105.4 |
105.4 |
106.5 |
105.4 |
105.4 |
105.3 |
106.6 |
105.4 |
105.1 |
104.8 |
105.0 |
1.8 |
2013-10-11 17:34 |
106.6 |
105.2 |
105.2 |
105.6 |
105.7 |
105.2 |
105.2 |
105.2 |
105.2 |
105.2 |
104.5 |
105.2 |
2.1 |
2013-10-11 17:35 |
105.7 |
105.3 |
105.6 |
105.2 |
105.8 |
105.5 |
105.3 |
105.3 |
105.3 |
105.2 |
105.4 |
106.5 |
1.3 |
2013-10-11 17:36 |
105.8 |
105.3 |
105.1 |
105.4 |
106.5 |
105.4 |
105.2 |
105.2 |
105.4 |
105.3 |
105.4 |
105.4 |
1.4 |
2013-10-11 17:37 |
105.3 |
105.2 |
105.4 |
105.3 |
106.4 |
105.6 |
105.4 |
106.5 |
105.7 |
105.2 |
105.2 |
105.2 |
1.3 |
2013-10-11 17:38 |
105.4 |
105.1 |
106.2 |
105.2 |
105.8 |
105.2 |
105.4 |
105.1 |
105.2 |
104.8 |
104.6 |
105.2 |
1.6 |
2013-10-11 17:39 |
105.5 |
105.4 |
105.2 |
105.1 |
106.7 |
105.3 |
106.3 |
105.4 |
105.3 |
105.4 |
105.3 |
105.4 |
1.6 |
2013-10-11 17:40 |
105.6 |
105.4 |
106.2 |
105.1 |
105.2 |
105.2 |
106.5 |
105.4 |
105.2 |
105.2 |
104.9 |
105.5 |
1.6 |
2013-10-11 17:41 |
105.3 |
105.3 |
106.2 |
105.3 |
105.3 |
105.4 |
106.4 |
105.2 |
105.4 |
105.3 |
105.4 |
105.2 |
1.2 |
2013-10-11 17:42 |
105.6 |
105.6 |
105.3 |
105.4 |
105.2 |
105.2 |
106.2 |
105.2 |
105.2 |
105.2 |
105.2 |
105.4 |
1.0 |
最大值 |
106.8 |
105.7 |
106.4 |
106.7 |
106.8 |
105.7 |
106.5 |
106.6 |
106.5 |
105.8 |
105.6 |
106.7 |
— |
最小值 |
105.2 |
105.1 |
105.0 |
105.1 |
104.9 |
105.0 |
104.8 |
105.1 |
105.2 |
104.8 |
104.5 |
104.8 |
— |
測試人 復核人 日期:
105℃滿載熱分布測試記錄(第3次)
設備編號:120406-02-01 溫度:105℃
位置
時間 |
1 |
2 |
3 |
4 |
5 |
6 |
7 |
8 |
9 |
10 |
11 |
12 |
△T |
2013-10-12 17:12 |
105.4 |
105.7 |
105.4 |
105.7 |
105.2 |
105.3 |
105.1 |
105.2 |
105.8 |
105.2 |
104.9 |
105.2 |
0.9 |
2013-10-12 17:13 |
105.4 |
105.3 |
105.2 |
105.1 |
105.4 |
105.1 |
105.2 |
105.3 |
105.5 |
105.2 |
104.8 |
105.0 |
0.7 |
2013-10-12 17:14 |
105.3 |
105.4 |
105.2 |
106.0 |
105.6 |
105.2 |
105.3 |
105.2 |
106.2 |
105.4 |
105.2 |
105.1 |
1.1 |
2013-10-12 17:15 |
106.1 |
105.3 |
105.0 |
106.2 |
105.3 |
105.3 |
105.1 |
105.4 |
106.4 |
105.2 |
105.2 |
105.4 |
1.4 |
2013-10-12 17:16 |
106.2 |
105.4 |
105.3 |
105.2 |
105.2 |
105.2 |
105.4 |
105.0 |
106.5 |
105.4 |
105.3 |
105.2 |
1.5 |
2013-10-12 17:17 |
106.5 |
105.5 |
105.2 |
106.4 |
105.1 |
105.0 |
105.5 |
105.6 |
106.4 |
105.3 |
104.6 |
105.3 |
1.9 |
2013-10-12 17:18 |
106.3 |
105.2 |
105.4 |
105.6 |
105.4 |
105.4 |
105.2 |
105.5 |
106.5 |
105.1 |
104.8 |
105.2 |
1.7 |
2013-10-12 17:19 |
105.8 |
105.4 |
105.2 |
106.2 |
105.5 |
105.4 |
105.5 |
105.6 |
105.2 |
105.3 |
104.2 |
105.1 |
2.0 |
2013-10-12 17:20 |
106.8 |
105.4 |
106.1 |
106.5 |
105.2 |
105.0 |
105.2 |
105.2 |
106.3 |
105.1 |
105.1 |
105.2 |
1.8 |
2013-10-12 17:21 |
106.4 |
105.3 |
106.2 |
105.7 |
106.2 |
105.1 |
105.4 |
105.2 |
106.5 |
105.2 |
104.9 |
106.7 |
1.8 |
2013-10-12 17:22 |
106.2 |
105.2 |
105.2 |
105.3 |
106.0 |
105.4 |
105.3 |
105.3 |
106.4 |
105.1 |
105.1 |
105.3 |
1.3 |
2013-10-12 17:23 |
106.1 |
105.5 |
105.4 |
105.6 |
105.4 |
105.5 |
105.2 |
105.4 |
106.2 |
105.4 |
105.2 |
106.4 |
1.2 |
2013-10-12 17:24 |
105.7 |
105.2 |
105.5 |
105.4 |
105.2 |
105.7 |
105.2 |
105.2 |
106.1 |
105.2 |
105.1 |
106.0 |
1.0 |
2013-10-12 17:25 |
105.8 |
105.6 |
105.2 |
106.7 |
106.4 |
105.4 |
105.1 |
105.8 |
105.4 |
105.4 |
104.7 |
106.4 |
2.0 |
2013-10-12 17:26 |
105.6 |
105.4 |
105.4 |
106.2 |
106.8 |
105.6 |
104.9 |
105.4 |
105.4 |
105.1 |
104.8 |
106.3 |
2.0 |
2013-10-12 17:27 |
105.3 |
105.1 |
106.3 |
106.1 |
105.3 |
105.2 |
105.3 |
105.6 |
105.2 |
105.2 |
105.3 |
105.6 |
1.2 |
2013-10-12 17:28 |
105.4 |
105.3 |
106.2 |
105.7 |
105.2 |
105.3 |
105.4 |
105.4 |
105.3 |
105.8 |
105.6 |
105.4 |
1.0 |
2013-10-12 17:29 |
105.3 |
105.6 |
105.2 |
105.9 |
106.2 |
105.8 |
105.3 |
105.8 |
105.3 |
105.4 |
104.6 |
106.1 |
1.6 |
2013-10-12 17:30 |
105.8 |
105.6 |
105.3 |
105.4 |
106.5 |
106.0 |
105.2 |
105.3 |
105.2 |
105.2 |
104.8 |
106.2 |
1.7 |
2013-10-12 17:31 |
105.4 |
105.6 |
105.2 |
105.3 |
104.9 |
106.2 |
105.6 |
106.5 |
105.4 |
105.5 |
105.2 |
105.3 |
1.6 |
2013-10-12 17:32 |
106.5 |
105.5 |
105.8 |
105.8 |
105.6 |
105.8 |
105.4 |
106.2 |
105.4 |
105.2 |
105.1 |
105.4 |
1.4 |
2013-10-12 17:33 |
106.2 |
105.4 |
105.4 |
106.5 |
105.4 |
105.5 |
105.3 |
106.3 |
105.4 |
105.1 |
104.8 |
105.5 |
1.7 |
2013-10-12 17:34 |
106.6 |
105.3 |
105.2 |
105.6 |
105.7 |
105.4 |
105.2 |
105.8 |
105.2 |
105.2 |
104.5 |
105.6 |
2.1 |
2013-10-12 17:35 |
105.2 |
105.3 |
105.6 |
105.3 |
105.8 |
105.5 |
105.2 |
105.7 |
105.8 |
105.2 |
105.4 |
105.7 |
0.6 |
2013-10-12 17:36 |
105.2 |
105.4 |
105.1 |
105.2 |
106.5 |
105.4 |
105.4 |
105.2 |
105.4 |
105.3 |
105.4 |
105.2 |
1.4 |
2013-10-12 17:37 |
105.3 |
105.3 |
105.4 |
105.4 |
106.4 |
105.6 |
105.2 |
106.5 |
105.7 |
105.2 |
105.2 |
105.8 |
1.3 |
2013-10-12 17:38 |
105.4 |
105.5 |
106.2 |
105.2 |
105.8 |
105.2 |
105.6 |
105.6 |
105.2 |
104.8 |
104.6 |
105.2 |
1.6 |
2013-10-12 17:39 |
105.4 |
105.6 |
105.2 |
105.6 |
106.7 |
105.3 |
106.1 |
105.4 |
105.4 |
105.4 |
105.3 |
105.4 |
1.5 |
2013-10-12 17:40 |
105.3 |
105.8 |
106.2 |
105.4 |
105.2 |
105.2 |
106.5 |
105.4 |
105.2 |
105.2 |
104.9 |
105.6 |
1.6 |
2013-10-12 17:41 |
105.4 |
105.6 |
106.2 |
105.3 |
105.3 |
105.4 |
106.4 |
105.2 |
105.6 |
105.3 |
105.4 |
105.2 |
1.2 |
2013-10-12 17:42 |
105.6 |
105.6 |
105.3 |
105.4 |
105.2 |
105.2 |
106.2 |
105.3 |
105.2 |
105.2 |
105.2 |
105.4 |
1.0 |
最大值 |
106.8 |
105.8 |
106.3 |
106.7 |
106.8 |
106.2 |
106.5 |
106.5 |
106.5 |
105.8 |
105.6 |
106.7 |
— |
最小值 |
105.2 |
105.1 |
105.0 |
105.1 |
104.9 |
105.0 |
104.9 |
105.0 |
105.2 |
104.8 |
104.2 |
105.0 |
— |
測試人 復核人 日期:
驗證結(jié)果報告書
題目 |
蒸汽滅菌柜驗證 |
目的/概要 |
檢查并確認蒸汽滅菌柜文件資料齊全,性能適應生產(chǎn)工藝要求,符合GMP要求。 |
評定結(jié)論 |
證實蒸汽滅菌柜滿足生產(chǎn)工藝要求,符合GMP要求。 |
驗證實施時間 |
2013年10月 |
負責者(部門) |
驗證小組 |
變更記錄(改定者、改定日、變更事項、理由) |
|
驗 證 證 書
茲證明
蒸汽滅菌柜
經(jīng)過驗證后,符合要求,準予投入生產(chǎn)使用。
驗證文件編號 |
SYZ-03-028-01 |
頒發(fā)部門 |
驗證工作領導小組 |
驗證部門 |
設備處 |
簽發(fā)人 |
|
簽發(fā)日期 |
年 月 日 |
批準人 |
|
有效期 |
個月 |
沈陽同聯(lián)藥業(yè)有限公司
文件名稱 |
蒸汽滅菌柜再驗證報告(2) |
編 號 |
SYZ-B-03-028-02 |
編制依據(jù) |
設備驗證管理制度(YZ01-002) |
共14頁 |
編 制 人 |
|
審 核 人 |
|
批 準 人 |
|
編制日期 |
年 月 日 |
審核日期 |
年 月 日 |
批準日期 |
年 月 日 |
頒發(fā)部門 |
設備處 |
生效日期 |
|
1、概述
蒸汽滅菌柜(YXQ-WF22)位于口服液滅菌室,生產(chǎn)廠家長春市醫(yī)用設備廠。本次蒸汽滅菌柜的驗證為再驗證。采用同步驗證的方式進行,對連續(xù)三批耆鹿逐痹口服液的藥液配制生產(chǎn),對蒸汽滅菌柜進行驗證。本次驗證不再進行設計驗證(DQ)及安裝驗證(IQ)。本方案的制定依據(jù)蒸汽滅菌柜(120406-02-02)標準操作規(guī)程進行制定。
由于該設備一直處于良好的運行狀態(tài),本次確認是在繼上次確認結(jié)束后,無任何偏差、變更情況下對設備性能進行的再確認,故在滅菌效果確認時,無需考察空載狀態(tài),如滿載及熱力分布溫度分布均一性能夠達到驗證可接受標準,即可證明設備性能穩(wěn)定。
2、驗證目的:
本再驗證方案的目的是以文件形式證明口服液生產(chǎn)用蒸汽滅菌柜和它的附件系統(tǒng)能夠按照預定運行范圍運行,在預先設定好的范圍內(nèi)生產(chǎn)產(chǎn)品。
3、驗證范圍:
口服液生產(chǎn)用蒸汽滅菌柜
4、驗證小組職責
驗證小組成員 |
部門及職位 |
職 責 |
組長 |
蘇振波 |
設備處處長 |
負責再驗證方案驗證報告的審批 |
組員 |
孫忠輝 |
機修車間主任 |
負責擬定方案,實施驗證,完成驗證報告。 |
沈偉 |
設備員 |
負責方案的實施驗證。 |
張若萍 |
計量室主任 |
負責儀器、儀表、器具等的校正。 |
包君 |
質(zhì)保處 |
參與和協(xié)調(diào)驗證工作。 |
袁玉敏 |
QA |
生產(chǎn)現(xiàn)場監(jiān)督員 |
孫桂菊 |
二車間主任 |
監(jiān)督驗證的實施 |
高云峰 |
生產(chǎn)技術(shù)員 |
參與驗證實施過程。 |
李麗華 |
質(zhì)量部部長 |
驗證方案及驗證報告的批準 |
鞠濤 |
總工程師 |
驗證方案及驗證報告的批準、發(fā)放驗證證書、驗證再驗證周期 |
魏影 |
總經(jīng)理 |
簽發(fā)驗證證書 |
5、驗證正文
5.1驗證過程中使用的儀器儀表校驗情況
本次所用計量器具及儀表等校驗情況。見附表1
5.2 運行確認
按蒸汽滅菌柜操作規(guī)程要求運行,對蒸汽滅菌柜的各項功能進行檢查。具體檢查項如下:
1)對設備外觀進行檢查,蒸汽滅菌柜內(nèi)外表面應無腐蝕或破損。
2)與四周、建筑物距離在0.20米以上有足夠的空間維護保養(yǎng)。
3)上蓋密封圈應完好無撕裂或老化現(xiàn)象。
4)管路應密封無泄漏。見附表2
5.3性能確認
5.3.1熱電偶放置方式的確認
將12支熱電偶放到滅菌鍋內(nèi)不同位置,測溫點不得接觸金屬表面和其它表面,具體放置位置見如下示意圖:
5.3.2觀察無紙記錄儀記錄運行溫度
取樣點及溫度探頭位置圖示:
圖一
取樣點分層 |
取樣點位置 |
熱電偶編號 |
取樣點位置 |
熱電偶編號 |
取樣點位置 |
熱電偶編號 |
1 |
01 |
2 |
02 |
3 |
03 |
4 |
04 |
5 |
05 |
4 |
06 |
7 |
07 |
8 |
08 |
9 |
09 |
10 |
10 |
11 |
11 |
12 |
12 |
滿載及熱力分布取樣點編號見附表1
5.3.2熱力分布溫度分布均一性確認
熱力分布溫度均一性確認在滿載狀態(tài)下進行,將溫度驗證儀探頭放在被滅菌的物品內(nèi)部,以考察滅菌效果。該項確認同樣在105℃/30min每個工藝參數(shù)條件下連續(xù)進行三次。
可接受標準:各測試點溫度與設定值溫差≤2℃
各測試點溫度范圍103—107℃;
6.3 數(shù)據(jù)統(tǒng)計及分析
分別統(tǒng)計滿載熱力分布均一性確認,統(tǒng)計結(jié)果如下。
105℃滿載溫度分布統(tǒng)計結(jié)果 單位:105℃
試驗次數(shù) |
項目 |
熱電偶編號 |
01 |
02 |
03 |
04 |
05 |
06 |
07 |
08 |
09 |
10 |
11 |
12 |
1 |
最大值 |
106.5 |
106.4 |
106.5 |
106.5 |
106.4 |
106.5 |
106.5 |
106.5 |
106.6 |
106.5 |
106.4 |
106.7 |
最小值 |
104.8 |
105.0 |
104.6 |
104.9 |
104.9 |
104.8 |
104.6 |
104.6 |
104.8 |
104.7 |
104.1 |
105.0 |
2 |
最大值 |
106.5 |
106.5 |
106.5 |
106.4 |
106.4 |
106.4 |
106.2 |
106.4 |
106.5 |
106.4 |
105.8 |
106.6 |
最小值 |
104.8 |
104.7 |
104.9 |
104.8 |
104.8 |
104.8 |
104.8 |
105.0 |
104.8 |
104.8 |
104.5 |
104.9 |
3 |
最大值 |
106.4 |
106.5 |
106.4 |
106.5 |
106.5 |
106.4 |
106.5 |
106.4 |
106.4 |
106.4 |
105.8 |
106.4 |
最小值 |
105.1 |
105.0 |
104.8 |
104.7 |
105.0 |
105.0 |
105.0 |
104.7 |
104.8 |
105.1 |
104.5 |
105.1 |
6.4 驗證合格標準
6.4.1該設備在滿載及熱力分布溫度均一性能達到相應的可接受標準。
6.5 變更與偏差處理
確認過程中如果出現(xiàn)偏差或變更,應立即通知質(zhì)保處,按照偏差處理程序或變更控制程序?qū)ζ涮幚?。所有偏差和變更按照相應?guī)程得到有效處理后,確認方可進入下一步驟。原始的偏差表或變更表經(jīng)過批準后,其復印件必須附在最終的確認報告中。
確認過程無變更與偏差。
評價結(jié)果:__________________。
6.7 確認結(jié)果評定與結(jié)論
驗證工作小組組長對確認結(jié)果進行綜合評審,做出確認結(jié)論。驗證領導小組組長發(fā)放驗證證書,對確認結(jié)果的評審應包括:
(1) 驗證結(jié)果是否有遺漏?
驗證結(jié)果: __________________。
(2) 驗證過程中的偏差、變更是否關(guān)閉?
驗證過程__________________。
(3) 驗證實施過程中對驗證方案有無修改,修改原因、依據(jù)、是否經(jīng)過批準?
驗證實施過程: __________________。
(4) 驗證記錄是否完整?
驗證記錄完整、真實
(5) 驗證結(jié)果是否符合標準要求?
驗證結(jié)果能夠達到驗證合格標準。
附表1
序號 |
儀器儀表名稱 |
型號 |
編號 |
范圍 |
校正日期 |
有效期 |
1 |
熱電偶 |
HSB-600R |
TI10-15-1-1 |
0~300℃ |
2013-03-26 |
一年 |
2 |
熱電偶 |
HSB-600R |
TI10-15-1-2 |
0~300℃ |
2013-03-26 |
一年 |
3 |
熱電偶 |
HSB-600R |
TI10-15-1-3 |
0~300℃ |
2013-03-26 |
一年 |
4 |
熱電偶 |
HSB-600R |
TI10-15-1-4 |
0~300℃ |
2013-03-26 |
一年 |
5 |
熱電偶 |
HSB-600R |
TI10-15-1-5 |
0~300℃ |
2013-03-26 |
一年 |
6 |
熱電偶 |
HSB-600R |
TI10-15-1-6 |
0~300℃ |
2013-03-26 |
一年 |
7 |
熱電偶 |
HSB-600R |
TI10-15-1-7 |
0~300℃ |
2013-03-26 |
一年 |
8 |
熱電偶 |
HSB-600R |
TI10-15-1-8 |
0~300℃ |
2013-03-26 |
一年 |
9 |
熱電偶 |
HSB-600R |
TI10-15-1-9 |
0~300℃ |
2013-03-26 |
一年 |
10 |
熱電偶 |
HSB-600R |
TI10-15-1-10 |
0~300℃ |
2013-03-26 |
一年 |
11 |
熱電偶 |
HSB-600R |
TI10-15-1-11 |
0~300℃ |
2013-03-26 |
一年 |
12 |
熱電偶 |
HSB-600R |
TI10-15-1-12 |
0~300℃ |
2013-03-26 |
一年 |
附表2:
設備運行確認表
項目 |
可接受標準 |
結(jié)果 |
結(jié)論 |
設備情況 |
蒸汽滅菌柜內(nèi)外表面應無腐蝕或破損。 |
|
|
位置 |
與四周、建筑物距離在0.20米以上有足夠的空間維護保養(yǎng) |
|
密封圈 |
上蓋密封圈應完好無撕裂或老化現(xiàn)象 |
|
管路 |
管路應密封無泄漏 |
|
檢查人 |
|
復核人 |
|
檢查日期 |
|
|
|
|
|
|
|
附表3:
105℃滿載熱分布測試記錄(第1次)
設備編號:120406-02-02
溫度:105℃
位置
時間 |
1 |
2 |
3 |
4 |
5 |
6 |
7 |
8 |
9 |
10 |
11 |
12 |
△T |
2013-10-10 17:12 |
105.2 |
105.3 |
105.3 |
105.3 |
105.0 |
105.4 |
105.2 |
105.2 |
106.2 |
105.1 |
104.8 |
105.2 |
1.4 |
2013-10-10 17:13 |
105.5 |
105.2 |
105.6 |
105.4 |
105.2 |
105.0 |
105.3 |
105.3 |
105.1 |
105.4 |
104.6 |
105.4 |
1.0 |
2013-10-10 17:14 |
105.2 |
105.4 |
105.4 |
105.2 |
105.8 |
105.6 |
105.5 |
105.4 |
105.9 |
105.1 |
105.1 |
105.6 |
0.8 |
2013-10-10 17:15 |
105.4 |
105.6 |
105.8 |
105.6 |
105.2 |
105.7 |
105.4 |
105.8 |
105.4 |
105.8 |
105.6 |
105.1 |
0.7 |
2013-10-10 17:16 |
105.6 |
105.4 |
105.2 |
105.8 |
105.4 |
105.2 |
105.2 |
105.3 |
106.1 |
105.2 |
105.8 |
105.8 |
0.9 |
2013-10-10 17:17 |
105.2 |
105.8 |
105.0 |
105.2 |
105.6 |
104.8 |
105.0 |
105.5 |
106.5 |
105.4 |
105.2 |
105.6 |
1.7 |
2013-10-10 17:18 |
105.4 |
106.4 |
105.8 |
105.0 |
105.4 |
105.2 |
105.1 |
105.0 |
106.0 |
105.9 |
105.4 |
105.0 |
1.4 |
2013-10-10 17:19 |
105.0 |
106.2 |
106.0 |
104.9 |
105.9 |
106.1 |
105.6 |
104.6 |
105.4 |
105.0 |
105.9 |
106.1 |
1.6 |
2013-10-10 17:20 |
104.8 |
106.0 |
106.2 |
105.6 |
106.1 |
106.5 |
105.3 |
104.9 |
106.1 |
105.6 |
106.2 |
106.3 |
1.7 |
2013-10-10 17:21 |
105.3 |
105.5 |
106.5 |
105.2 |
106.2 |
105.2 |
105.6 |
105.0 |
106.2 |
105.9 |
105.1 |
106.7 |
1.7 |
2013-10-10 17:22 |
105.6 |
105.3 |
105.7 |
105.0 |
106.1 |
105.6 |
105.0 |
105.6 |
106.6 |
106.1 |
105.8 |
105.7 |
1.6 |
2013-10-10 17:23 |
105.8 |
105.4 |
105.3 |
106.2 |
105.1 |
105.0 |
104.6 |
105.7 |
106.0 |
106.5 |
105.2 |
105.2 |
1.9 |
2013-10-10 17:24 |
106.2 |
105.6 |
105.6 |
104.9 |
105.6 |
105.4 |
105.8 |
105.0 |
105.3 |
106.0 |
105.7 |
105.6 |
1.3 |
2013-10-10 17:25 |
106.5 |
105.2 |
105.3 |
105.8 |
105.0 |
105.8 |
105.2 |
105.3 |
105.8 |
105.4 |
105.6 |
105.1 |
1.5 |
2013-10-10 17:26 |
105.9 |
105.7 |
105.4 |
106.2 |
105.9 |
105.3 |
105.1 |
105.6 |
105.4 |
105.9 |
106.3 |
105.8 |
1.2 |
2013-10-10 17:27 |
106.2 |
105.3 |
106.2 |
106.5 |
106.1 |
106.0 |
105.6 |
105.0 |
105.0 |
105.2 |
106.0 |
105.4 |
1.5 |
2013-10-10 17:28 |
106.1 |
105.8 |
106.2 |
106.4 |
105.2 |
106.3 |
105.2 |
105.8 |
104.8 |
105.4 |
105.7 |
105.2 |
1.6 |
2013-10-10 17:29 |
106.3 |
105.2 |
105.8 |
105.2 |
106.2 |
105.2 |
105.6 |
105.2 |
105.4 |
104.7 |
105.3 |
105.9 |
1.6 |
2013-10-10 17:30 |
105.8 |
105.4 |
106.0 |
105.0 |
105.5 |
106.2 |
105.4 |
105.9 |
105.9 |
104.9 |
105.6 |
106.2 |
1.3 |
2013-10-10 17:31 |
105.4 |
105.9 |
106.2 |
105.3 |
104.9 |
106.4 |
105.0 |
106.1 |
105.1 |
105.2 |
105.8 |
105.2 |
1.5 |
2013-10-10 17:32 |
105.7 |
105.2 |
106.5 |
105.6 |
105.4 |
105.6 |
105.8 |
106.5 |
105.6 |
105.6 |
105.0 |
105.6 |
1.5 |
2013-10-10 17:33 |
105.3 |
105.0 |
106.0 |
105.4 |
105.1 |
106.1 |
105.0 |
106.0 |
105.4 |
105.9 |
105.4 |
105.5 |
1.1 |
2013-10-10 17:34 |
105.6 |
105.2 |
105.8 |
105.2 |
105.8 |
106.2 |
105.4 |
105.6 |
105.0 |
105.2 |
105.7 |
106.0 |
1.2 |
2013-10-10 17:35 |
105.2 |
105.4 |
105.6 |
105.6 |
105.2 |
106.4 |
104.8 |
105.3 |
105.7 |
105.7 |
106.2 |
106.4 |
1.6 |
2013-10-10 17:36 |
105.5 |
105.3 |
105.2 |
105.0 |
106.1 |
105.8 |
104.7 |
105.4 |
105.1 |
105.9 |
106.4 |
105.2 |
1.7 |
2013-10-10 17:37 |
105.8 |
105.7 |
105.3 |
105.5 |
106.4 |
105.5 |
105.0 |
106.2 |
105.8 |
106.4 |
105.2 |
105.8 |
1.4 |
2013-10-10 17:38 |
105.6 |
105.2 |
104.8 |
105.7 |
105.7 |
105.6 |
105.5 |
105.3 |
104.8 |
105.7 |
105.8 |
105.4 |
1.0 |
2013-10-10 17:39 |
105.4 |
105.6 |
104.6 |
105.0 |
105.2 |
105.1 |
105.9 |
105.9 |
105.6 |
105.2 |
105.6 |
105.6 |
1.3 |
2013-10-10 17:40 |
105.0 |
105.1 |
105.7 |
104.9 |
105.6 |
104.9 |
106.5 |
105.1 |
105.0 |
105.8 |
105.1 |
105.1 |
1.6 |
2013-10-10 17:41 |
106.2 |
105.6 |
105.2 |
105.8 |
105.0 |
105.5 |
106.2 |
105.5 |
105.8 |
105.0 |
105.0 |
105.4 |
1.2 |
2013-10-10 17:42 |
105.2 |
105.4 |
105.3 |
105.0 |
105.2 |
105.6 |
106.0 |
105.4 |
105.2 |
105.2 |
104.1 |
105.7 |
1.9 |
最大值 |
121.3 |
121.7 |
121.2 |
122.3 |
121.6 |
121.4 |
121.7 |
122.7 |
120.3 |
122.8 |
121.7 |
121.6 |
— |
最小值 |
120.6 |
121.0 |
120.6 |
121.7 |
120.8 |
120.9 |
121.1 |
122.2 |
119.3 |
121.8 |
120.7 |
121.0 |
— |
測試人 復核人: 日期:
105℃滿載熱分布測試記錄(第2次)
設備編號:120406-02-02
溫度:105℃
位置
時間 |
1 |
2 |
3 |
4 |
5 |
6 |
7 |
8 |
9 |
10 |
11 |
12 |
△T |
2013-10-11 17:12 |
105.1 |
105.7 |
105.3 |
105.4 |
105.0 |
105.2 |
105.3 |
105.0 |
104.8 |
105.3 |
104.6 |
105.5 |
1.1 |
2013-10-11 17:13 |
105.6 |
105.3 |
105.5 |
105.1 |
105.3 |
105.6 |
105.4 |
105.4 |
105.2 |
105.5 |
104.8 |
105.4 |
0.8 |
2013-10-11 17:14 |
105.2 |
105.4 |
105.4 |
105.3 |
105.4 |
105.5 |
105.6 |
105.5 |
106.1 |
105.9 |
105.2 |
105.2 |
0.9 |
2013-10-11 17:15 |
105.8 |
105.3 |
105.8 |
105.8 |
105.6 |
105.4 |
105.8 |
105.2 |
106.4 |
105.1 |
105.2 |
105.8 |
1.3 |
2013-10-11 17:16 |
105.2 |
105.4 |
106.2 |
106.0 |
105.9 |
105.8 |
105.2 |
105.6 |
105.6 |
105.5 |
105.3 |
105.2 |
1.0 |
2013-10-11 17:17 |
105.6 |
105.5 |
106.1 |
106.2 |
106.1 |
106.2 |
105.8 |
105.9 |
105.1 |
105.8 |
105.6 |
105.6 |
1.1 |
2013-10-11 17:18 |
106.1 |
105.2 |
106.5 |
106.0 |
106.4 |
106.1 |
105.1 |
105.4 |
105.3 |
106.1 |
105.1 |
105.4 |
1.4 |
2013-10-11 17:19 |
106.5 |
105.4 |
105.7 |
105.8 |
106.0 |
105.8 |
105.6 |
105.3 |
105.6 |
106.2 |
105.8 |
105.1 |
1.4 |
2013-10-11 17:20 |
106.0 |
105.2 |
105.6 |
105.3 |
105.8 |
105.2 |
105.4 |
105.8 |
105.8 |
106.2 |
105.2 |
104.9 |
1.3 |
2013-10-11 17:21 |
105.2 |
105.4 |
105.2 |
105.6 |
105.4 |
105.6 |
105.0 |
106.2 |
105.4 |
105.8 |
105.0 |
105.2 |
1.2 |
2013-10-11 17:22 |
104.8 |
105.9 |
105.4 |
105.4 |
105.6 |
105.5 |
105.2 |
106.0 |
105.0 |
105.2 |
104.8 |
105.5 |
1.2 |
2013-10-11 17:23 |
105.2 |
105.1 |
105.8 |
105.9 |
105.2 |
105.7 |
105.4 |
105.8 |
104.9 |
105.5 |
104.9 |
105.6 |
1.0 |
2013-10-11 17:24 |
105.8 |
105.5 |
105.3 |
106.2 |
105.7 |
105.9 |
105.8 |
105.5 |
105.5 |
105.9 |
104.6 |
105.7 |
1.6 |
2013-10-11 17:25 |
105.2 |
105.6 |
105.0 |
105.4 |
105.9 |
106.2 |
105.1 |
105.1 |
105.6 |
105.4 |
104.5 |
106.1 |
1.7 |
2013-10-11 17:26 |
105.6 |
105.8 |
104.9 |
105.0 |
106.2 |
106.4 |
104.8 |
105.6 |
105.8 |
105.6 |
105.0 |
106.3 |
1.6 |
2013-10-11 17:27 |
105.7 |
106.2 |
105.2 |
104.8 |
106.4 |
106.2 |
105.5 |
105.3 |
105.2 |
105.5 |
105.5 |
106.6 |
1.8 |
2013-10-11 17:28 |
105.0 |
106.1 |
105.7 |
105.2 |
106.0 |
105.3 |
105.2 |
105.4 |
105.9 |
105.8 |
105.8 |
105.8 |
1.1 |
2013-10-11 17:29 |
104.9 |
105.2 |
105.9 |
105.6 |
105.7 |
105.8 |
105.4 |
105.8 |
105.2 |
106.1 |
105.3 |
105.3 |
1.2 |
2013-10-11 17:30 |
105.8 |
105.1 |
106.2 |
105.9 |
105.6 |
105.6 |
105.1 |
105.6 |
105.8 |
106.4 |
105.6 |
105.7 |
1.3 |
2013-10-11 17:31 |
105.2 |
105.4 |
105.2 |
105.4 |
105.1 |
105.4 |
105.6 |
105.4 |
106.1 |
105.5 |
105.4 |
105.2 |
1.0 |
2013-10-11 17:32 |
105.6 |
104.8 |
105.4 |
105.2 |
105.5 |
105.2 |
105.2 |
105.3 |
106.2 |
105.2 |
105.2 |
105.8 |
1.4 |
2013-10-11 17:33 |
105.9 |
104.7 |
105.0 |
105.6 |
105.9 |
105.5 |
105.4 |
106.2 |
106.5 |
105.6 |
104.8 |
105.5 |
1.8 |
2013-11-11 17:34 |
105.2 |
105.2 |
105.2 |
105.8 |
105.4 |
105.8 |
105.6 |
106.4 |
105.8 |
105.6 |
104.5 |
105.2 |
1.9 |
2013-10-11 17:35 |
105.9 |
105.3 |
105.4 |
105.4 |
105.2 |
106.2 |
105.0 |
106.3 |
105.2 |
105.0 |
105.2 |
105.6 |
1.3 |
2013-10-11 17:36 |
106.1 |
105.8 |
105.8 |
105.8 |
105.5 |
105.2 |
104.8 |
105.2 |
105.6 |
104.9 |
105.4 |
105.2 |
1.3 |
2013-10-11 17:37 |
106.4 |
105.4 |
105.3 |
106.2 |
105.8 |
104.9 |
104.9 |
105.5 |
105.7 |
105.2 |
105.3 |
105.9 |
1.5 |
2013-10-11 17:38 |
106.3 |
105.9 |
105.4 |
106.4 |
105.6 |
105.4 |
105.5 |
105.6 |
105.9 |
104.8 |
105.2 |
105.5 |
1.6 |
2013-10-11 17:39 |
105.8 |
106.5 |
106.1 |
105.7 |
105.4 |
104.8 |
105.8 |
105.9 |
105.2 |
105.5 |
105.6 |
105.0 |
1.7 |
2013-10-11 17:40 |
105.6 |
106.2 |
106.2 |
105.3 |
105.2 |
105.3 |
106.0 |
106.0 |
105.2 |
105.8 |
105.2 |
105.3 |
1.0 |
2013-10-11 17:41 |
105.4 |
105.5 |
105.6 |
105.2 |
104.8 |
105.5 |
106.2 |
105.4 |
105.6 |
105.2 |
105.5 |
105.7 |
1.4 |
2013-10-11 17:42 |
105.3 |
105.6 |
105.3 |
105.6 |
104.9 |
105.6 |
106.2 |
105.2 |
105.2 |
105.6 |
105.2 |
105.4 |
1.3 |
2013-10-11 17:12 |
105.1 |
105.7 |
105.3 |
105.4 |
105.0 |
105.2 |
105.3 |
105.0 |
104.8 |
105.3 |
104.6 |
105.5 |
1.1 |
2013-10-11 17:13 |
105.6 |
105.3 |
105.5 |
105.1 |
105.3 |
105.6 |
105.4 |
105.4 |
105.2 |
105.5 |
104.8 |
105.4 |
0.8 |
測試人 復核人: 日期:
105℃滿載熱分布測試記錄(第3次)
設備編號:120406-02-02 溫度:105℃
位置
時間 |
1 |
2 |
3 |
4 |
5 |
6 |
7 |
8 |
9 |
10 |
11 |
12 |
△T |
2013-10-12 17:12 |
105.2 |
105.2 |
105.2 |
105.6 |
105.2 |
106.2 |
105.6 |
105.2 |
105.8 |
105.6 |
105.2 |
105.2 |
1.0 |
2013-10-12 17:13 |
105.5 |
105.6 |
105.5 |
105.4 |
105.5 |
106.1 |
105.2 |
105.5 |
105.3 |
105.1 |
104.8 |
105.5 |
1.3 |
2013-10-12 17:14 |
105.6 |
105.2 |
105.8 |
105.5 |
105.0 |
105.8 |
105.5 |
105.6 |
105.6 |
105.8 |
105.2 |
105.6 |
0.8 |
2013-10-12 17:15 |
105.8 |
105.8 |
105.2 |
105.6 |
105.7 |
105.0 |
105.4 |
105.1 |
105.8 |
105.9 |
105.1 |
105.8 |
0.9 |
2013-10-12 17:16 |
105.2 |
105.2 |
105.5 |
105.8 |
105.3 |
105.5 |
105.8 |
105.0 |
105.4 |
106.2 |
105.4 |
105.7 |
1.2 |
2013-10-12 17:17 |
105.6 |
105.9 |
105.0 |
106.2 |
105.2 |
105.4 |
105.6 |
105.5 |
105.2 |
105.4 |
105.3 |
105.2 |
1.2 |
2013-10-12 17:18 |
105.9 |
106.0 |
104.8 |
106.0 |
105.6 |
105.2 |
105.4 |
105.8 |
104.8 |
105.5 |
105.8 |
105.4 |
1.2 |
2013-10-12 17:19 |
106.1 |
105.3 |
104.9 |
106.4 |
105.8 |
105.6 |
105.5 |
106.0 |
105.2 |
106.0 |
105.6 |
105.6 |
1.5 |
2013-10-12 17:20 |
105.7 |
105.8 |
105.5 |
106.5 |
106.2 |
105.8 |
105.0 |
106.2 |
105.5 |
106.1 |
105.2 |
105.2 |
1.5 |
2013-10-12 17:21 |
105.5 |
105.2 |
105.2 |
105.9 |
106.4 |
106.4 |
105.5 |
106.4 |
105.6 |
105.2 |
105.1 |
105.5 |
1.3 |
2013-10-12 17:22 |
106.2 |
105.5 |
105.6 |
105.6 |
106.0 |
106.2 |
105.9 |
106.0 |
105.4 |
105.7 |
104.6 |
105.8 |
1.6 |
2013-10-12 17:23 |
106.0 |
105.2 |
105.7 |
105.2 |
105.8 |
105.8 |
106.2 |
105.9 |
105.7 |
106.2 |
105.1 |
106.2 |
1.1 |
2013-10-12 17:24 |
106.2 |
105.8 |
105.2 |
105.0 |
105.5 |
105.2 |
106.5 |
105.2 |
105.9 |
106.4 |
104.8 |
106.0 |
1.7 |
2013-10-12 17:25 |
106.2 |
106.2 |
105.6 |
105.8 |
105.2 |
105.5 |
106.3 |
105.5 |
106.2 |
105.8 |
105.5 |
106.4 |
1.2 |
2013-10-12 17:26 |
106.4 |
106.0 |
105.4 |
106.2 |
105.6 |
105.6 |
105.8 |
105.4 |
106.4 |
105.6 |
105.2 |
105.7 |
1.2 |
2013-10-12 17:27 |
105.6 |
105.8 |
105.1 |
106.3 |
105.4 |
105.7 |
105.7 |
105.6 |
106.1 |
105.2 |
105.4 |
105.5 |
1.2 |
2013-10-12 17:28 |
105.1 |
105.0 |
105.6 |
105.7 |
105.7 |
105.9 |
105.2 |
105.7 |
105.8 |
105.7 |
105.6 |
105.3 |
0.9 |
2013-10-12 17:29 |
105.3 |
105.2 |
105.2 |
105.5 |
106.0 |
105.4 |
105.5 |
105.8 |
105.6 |
105.6 |
105.8 |
105.4 |
0.8 |
2013-10-12 17:30 |
105.4 |
105.6 |
105.8 |
105.2 |
106.2 |
105.8 |
105.6 |
105.1 |
105.4 |
105.2 |
105.2 |
105.2 |
1.1 |
2013-10-12 17:31 |
105.6 |
105.0 |
106.2 |
105.4 |
106.5 |
106.2 |
105.4 |
105.6 |
105.3 |
105.5 |
105.7 |
105.1 |
1.5 |
2013-10-12 17:32 |
105.8 |
105.3 |
106.4 |
105.6 |
106.1 |
106.4 |
105.3 |
105.4 |
105.5 |
105.5 |
105.2 |
105.4 |
1.2 |
2013-10-12 17:33 |
105.2 |
105.7 |
106.2 |
105.1 |
105.8 |
106.0 |
105.2 |
105.8 |
105.7 |
105.4 |
105.2 |
105.7 |
1.1 |
2013-10-12 17:34 |
105.9 |
106.2 |
106.0 |
105.8 |
105.3 |
105.8 |
105.5 |
105.2 |
105.9 |
105.2 |
105.0 |
105.6 |
1.2 |
2013-10-12 17:35 |
106.2 |
106.5 |
105.7 |
104.7 |
105.0 |
105.5 |
105.4 |
105.0 |
106.2 |
105.6 |
104.8 |
105.9 |
1.8 |
2013-10-12 17:36 |
105.5 |
106.0 |
105.5 |
105.2 |
105.4 |
105.2 |
105.7 |
104.9 |
106.0 |
105.8 |
104.6 |
105.4 |
1.4 |
2013-10-12 17:37 |
105.2 |
105.8 |
105.2 |
105.6 |
105.5 |
105.0 |
105.9 |
104.7 |
105.7 |
105.9 |
104.5 |
105.6 |
1.4 |
2013-10-12 17:38 |
105.5 |
105.2 |
105.4 |
105.4 |
105.6 |
105.6 |
106.2 |
105.2 |
105.3 |
105.3 |
104.9 |
105.4 |
1.3 |
2013-10-12 17:39 |
105.6 |
105.5 |
105.6 |
105.2 |
105.8 |
105.8 |
106.0 |
105.6 |
105.6 |
105.2 |
105.2 |
105.4 |
0.8 |
2013-10-12 17:40 |
105.8 |
105.2 |
105.1 |
105.6 |
105.4 |
105.5 |
106.4 |
105.8 |
105.4 |
105.3 |
105.4 |
105.6 |
1.3 |
2013-10-12 17:41 |
105.4 |
105.5 |
106.0 |
105.7 |
105.2 |
105.2 |
106.3 |
105.2 |
105.2 |
105.1 |
105.6 |
105.1 |
1.2 |
2013-10-12 17:42 |
105.6 |
105.6 |
105.3 |
105.9 |
105.2 |
105.6 |
105.8 |
105.4 |
105.8 |
105.2 |
105.2 |
105.4 |
0.7 |
2013-10-12 17:12 |
105.2 |
105.2 |
105.2 |
105.6 |
105.2 |
106.2 |
105.6 |
105.2 |
105.8 |
105.6 |
105.2 |
105.2 |
1.0 |
2013-10-12 17:13 |
105.5 |
105.6 |
105.5 |
105.4 |
105.5 |
106.1 |
105.2 |
105.5 |
105.3 |
105.1 |
104.8 |
105.5 |
1.3 |
測試人 復核人: 日期:
驗證結(jié)果報告書
題目 |
蒸汽滅菌柜驗證 |
目的/概要 |
檢查并確認蒸汽滅菌柜文件資料齊全,性能適應生產(chǎn)工藝要求,符合GMP要求。 |
評定結(jié)論 |
證實蒸汽滅菌柜滿足生產(chǎn)工藝要求,符合GMP要求。 |
驗證實施時間 |
2013年10月 |
負責者(部門) |
驗證小組 |
變更記錄(改定者、改定日、變更事項、理由) |
|
驗 證 證 書
茲證明
蒸汽滅菌柜
經(jīng)過驗證后,符合要求,準予投入生產(chǎn)使用。
驗證文件編號 |
SYZ-03-028-02 |
頒發(fā)部門 |
驗證工作領導小組 |
驗證部門 |
設備處 |
簽發(fā)人 |
|
簽發(fā)日期 |
年 月 日 |
批準人 |
|
有效期 |
個月 |